Labor LongPhase 4NCT05782816
Low-Dose Versus High-Dose Oxytocin Dosing for Induction and Augmentation of Labor
A Phase 4 study testing Oxytocin (Low dose) and Oxytocin (High dose) in people with Labor Long, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
The goal of this clinical trial is to compare oxytocin infusion rates for induction and augmentation of labor in nulliparous women. The main question[s] it aims to answer are: Does a high dose oxytocin infusion protocol affect length of induction to delivery interval? Does a high dose oxytocin infusion protocol affect… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Labor Long
- What is being tested?
- Oxytocin (Low dose) and Oxytocin (High dose)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2023to 24 Jun 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18-50 years old
- Singleton gestation
- Nulliparous
- Vertex presentation
- Gestational age greater than or equal to 37 weeks
- No prior uterine surgery
- Presents for elective or medically indicated induction of labor
- Need for augmentation of labor with oxytocin
Who cannot join
- Previous cervical ripening using non-mechanical methods
- Patient unable or unwilling to provide verbal consent
- Contraindications to vaginal delivery
- Fetal demise or life-limiting anomaly
- Allergy to oxytocin
- Non-reassuring fetal heart tracing prior to inclusion
- Maternal pulmonary edema prior to inclusion
- Fetal growth restriction
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch
Galveston, Texas, 77555
About this study
Official title: Low-Dose Versus High-Dose Oxytocin Dosing for Induction and Augmentation of Labor: A Randomized Control Trial
The goal of this clinical trial is to compare oxytocin infusion rates for induction and augmentation of labor in nulliparous women. The main question[s] it aims to answer are:
- Does a high dose oxytocin infusion protocol affect length of induction to delivery interval?
- Does a high dose oxytocin infusion protocol affect mode of delivery?
- Does a high dose oxytocin infusion protocol affect maternal and neonatal outcomes?
Read more
Participants will be randomized to either low- or high-dose oxytocin groups:
- The low dose group will receive an infusion to start at 2 milli-units/min and will be increased by 2 milli-units/min every 20 minutes. The maximum rate of infusion is 40 milli-units/min.
- The high dose group will receive an infusion to start at 6 milli-units/min and will be increased by 6 milli-units/min every 20 minutes. Maximum rate of infusion is 40 milli-units/min.
- Conditions
- Labor Long
- Being tested
- Oxytocin (Low dose), Oxytocin (High dose)
- Keywords
- induction of labor, augmentation of labor, oxytocin, pitocin, high dose, mode of delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxytocin (Low dose)Drug
Also called Pitocin, Syntocinon
Low dose oxytocin
Oxytocin (High dose)Drug
Also called Pitocin, Syntocinon
High dose oxytocin
| Study group | Role | What they receive |
|---|---|---|
| Low dose oxytocin | Active comparator | The low dose oxytocin group will receive a controlled infusion pump at a proximal port on the peripheral IV line. The infusion will start at 2 milli-units/min and will be increased by 2 milli-units/min every 20 minutes. Maximum rate of infusion is 40 milli-units/min. Oxytocin infusion rate is adjusted to maintain adequate uterine contractions. Receives: Drug: Oxytocin (Low dose) |
| High dose oxytocin | Active comparator | The high dose oxytocin group will receive a controlled infusion pump at a proximal port on the peripheral IV line. The infusion will start at 6 milli-units/min and will be increased by 6 milli-units/min every 20 minutes. Maximum rate of infusion is 40 milli-units/min. Oxytocin infusion rate is adjusted to maintain adequate uterine contractions. Receives: Drug: Oxytocin (High dose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Delivery
Induction to delivery time interval
Measured: Through delivery, on average 24 hours
Secondary outcomes (12)
Mode of Delivery
Vaginal or cesarean delivery
Measured: Through delivery, on average 24 hours
Rate of Primary Cesarean Delivery
Number of participants with primary cesarean delivery.
Measured: Through delivery, on average 24 hours
Maximum Dose of Oxytocin Infusion
The highest oxytocin infusion rate administered to a participant during the study period.
Measured: Through delivery, on average 24 hours
Rate of Uterine Tachysystole
The number of participants with and without fetal heart rate changes and the need for cessation or decrease in oxytocin dosage.
Measured: Through delivery, on average 24 hours
Number of Participants With Postpartum Hemorrhage
Measured: From delivery through the postpartum period (average duration approximately 24 hours)
Rate of Placental Abruption
The number of participants with placental abruption.
Measured: Through delivery, on average 24 hours
Number of Participants With Nausea/Vomiting Requiring Antiemetics and Diarrhea
Measured: From delivery (average duration approximately 24 hours)
Rate of Maternal Infection (Endometritis, Chorioamnionitis)
The number of participants with maternal maternal infections (endometritis, choriomnionitis)
Measured: Through delivery, on average 24 hours
Rate of Serious Maternal Morbidity and Mortality
The number of participants with uterine rupture, admission to ICU, and septicemia or mortality.
Measured: Through delivery, on average 24 hours
Number of Neonates With One or More of: Perinatal Death, Severe Respiratory Distress Requiring Ventilation, Neonatal Encephalopathy, Neonatal Seizure, Neonatal Sepsis, 5-minute APGAR Score <7, Umbilical Artery Acidemia, Neonatal ICU Admission
Measured: From birth through 24 hours
Number of Participants With Neonatal Sepsis (Confirmed With Cultures)
Measured: From birth through 24 hours
Rate of Umbilical Artery Acidemia (Base Excess <12)
Number of participants with umbilical artery acidemia (base excess <12).
Measured: Through delivery, on average 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start17 Apr 2023
- Primary completion31 Dec 2024
- Study completion24 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Labor LongStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Medical Branch, Galveston
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amanda Wang, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05782816
- Sponsor's protocol ID
- 22-0240
- Status last verified
- Dec 2025
- First submitted
- 21 Feb 2023
- Last updated
- 9 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Dose Versus High-Dose Oxytocin Dosing for Induction and Augmentation of Labor: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05782816
- Acronym / sponsor ID
- 22-0240
- Conditions
- Labor Long
- Keywords
- induction of labor, augmentation of labor, oxytocin, pitocin, high dose, mode of delivery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 24 Jun 2025 (actual)
- First posted
- 24 Mar 2023 (actual)
- Results
- Posted 9 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare oxytocin infusion rates for induction and augmentation of labor in nulliparous women. The main question[s] it aims to answer are:
- Does a high dose oxytocin infusion protocol affect length of induction to delivery interval?
- Does a high dose oxytocin infusion protocol affect mode of delivery?
- Does a high dose oxytocin infusion protocol affect maternal and neonatal outcomes?
Participants will be randomized to either low- or high-dose oxytocin groups:
- The low dose group will receive an infusion to start at 2 milli-units/min and will be increased by 2 milli-units/min every 20 minutes. The maximum rate of infusion is 40 milli-units/min.
- The high dose group will receive an infusion to start at 6 milli-units/min and will be increased by 6 milli-units/min every 20 minutes. Maximum rate of infusion is 40 milli-units/min.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose oxytocin | Active comparator | Drug: Oxytocin (Low dose)The low dose oxytocin group will receive a controlled infusion pump at a proximal port on the peripheral IV line. The infusion will start at 2 milli-units/min and will be increased by 2 milli-units/min every 20 minutes. Maximum rate of infusion is 40 milli-units/min. Oxytocin infusion rate is adjusted to maintain adequate uterine contractions. |
| High dose oxytocin | Active comparator | Drug: Oxytocin (High dose)The high dose oxytocin group will receive a controlled infusion pump at a proximal port on the peripheral IV line. The infusion will start at 6 milli-units/min and will be increased by 6 milli-units/min every 20 minutes. Maximum rate of infusion is 40 milli-units/min. Oxytocin infusion rate is adjusted to maintain adequate uterine contractions. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Women aged 18-50 years old
- Singleton gestation
- Nulliparous
- Vertex presentation
- Gestational age greater than or equal to 37 weeks
Key exclusion criteria (8 listed)
- Previous cervical ripening using non-mechanical methods
- Patient unable or unwilling to provide verbal consent
- Contraindications to vaginal delivery
- Fetal demise or life-limiting anomaly
- Allergy to oxytocin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxytocin (Low dose)Also: Pitocin, SyntocinonLow dose oxytocin | Drug | Low dose oxytocin |
| Oxytocin (High dose)Also: Pitocin, SyntocinonHigh dose oxytocin | Drug | High dose oxytocin |
Primary outcome
Time to Delivery
Time frame: Through delivery, on average 24 hours
Induction to delivery time interval
12 secondary outcomes
Mode of Delivery
Time frame: Through delivery, on average 24 hours
Rate of Primary Cesarean Delivery
Time frame: Through delivery, on average 24 hours
Maximum Dose of Oxytocin Infusion
Time frame: Through delivery, on average 24 hours
Rate of Uterine Tachysystole
Time frame: Through delivery, on average 24 hours
Number of Participants With Postpartum Hemorrhage
Time frame: From delivery through the postpartum period (average duration approximately 24 hours)
Rate of Placental Abruption
Time frame: Through delivery, on average 24 hours
Number of Participants With Nausea/Vomiting Requiring Antiemetics and Diarrhea
Time frame: From delivery (average duration approximately 24 hours)
Rate of Maternal Infection (Endometritis, Chorioamnionitis)
Time frame: Through delivery, on average 24 hours
Rate of Serious Maternal Morbidity and Mortality
Time frame: Through delivery, on average 24 hours
Number of Neonates With One or More of: Perinatal Death, Severe Respiratory Distress Requiring Ventilation, Neonatal Encephalopathy, Neonatal Seizure, Neonatal Sepsis, 5-minute APGAR Score <7, Umbilical Artery Acidemia, Neonatal ICU Admission
Time frame: From birth through 24 hours
Number of Participants With Neonatal Sepsis (Confirmed With Cultures)
Time frame: From birth through 24 hours
Rate of Umbilical Artery Acidemia (Base Excess <12)
Time frame: Through delivery, on average 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda Wang, MD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxytocin (Low dose) and Oxytocin (High dose) in people with Labor Long, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Delivery (time frame: Through delivery, on average 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.